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Acer's shares drop 80% as FDA rejects drug for vascular Ehlers-Danlos syndrome

Published on 26/06/19 at 11:41am

Acer Therapeutics has seen its share value plunge by 80% after it emerged that the FDA had turned down its drug application for Edsivo (celiprolol) in the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation.

In the complete response letter sent to the firm by the US regulator, concerns were raised over the integrity of the clinical trial data submitted in support of the application.

The data submitted was derived from a study involving 53 participants with vEDS; upon analysis, the data demonstrated that Edsivo significantly reduced the risk of arterial dissection or rupture versus placebo.

In order to assuage these concerns over the drug’s efficacy, Acer will now be required to generate additional data for submission through new clinical trials to prove that the drug effectively reduces the risk of clinical events in vEDS patients.

“We remain committed to working closely with the FDA to fully understand its response,” said Chris Schelling, Acer’s Founder and CEO. “We expect to respond to the FDA in the third quarter of this year.”

Matt Fellows

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